340B Rebate Fight Returns to Court

After the D.C. Circuit ruled this summer that drug manufacturers can’t impose 340B rebate models without HHS approval, the Health Resources and Services Administration (HRSA) established its own rebate pilot and approved plans from 10 manufacturers for a January 1, 2027, launch. Now, hospitals are opening a new front in the legal debate. The American Hospital Association, Maine Hospital Association and four safety-net hospitals sued HHS on October 9th, arguing the revised pilot doesn’t adequately account for the administrative burden and cash-flow realities of requiring covered entities to pay higher prices up front and later fight for rebates. The plaintiffs are seeking to block implementation, but for now, the pilot remains scheduled for launch.